Evaluation of the Efficacy and Safety of Efinaconazole 10% Topical Solution for the Treatment of Toenail Onychomycosis: A Multicenter, Single-arm, Open-label Phase 4 Study

Background: Onychomycosis is a common nail fungal infection that affects the nail bed, plate, and matrix. It accounts for ~50% of all nail diseases. The treatment of onychomycosis includes systemic and topical approaches, which depend on patient compliance, drug penetration and delivery to the nail bed, antifungal efficacy, andtolerance. Efinaconazole is a novel triazole antifungal agent that is active against many pathogenic fungi, and is used for treating onychomycosis.Objective: To confirm the efficacy and safety of 10% efinaconazole solution for treating onychomycosis.Methods: This study was conducted as a 52-week, multicenter, open, single-group, phase 4 clinical trial. A 10% efinaconazole solution was applied on the toenails of each subject before bedtime, once a day for 48 weeks. The subjects visited the test facility every four weeks for the evaluation of the efficacy and safety of the treatment.Results: At 52 weeks of applying 10% efinaconazole solution, the rates of complete cure, mycological cure, complete or almost complete cure, and clinical effectiveness were 16.7%, 95.8%, 38.54%, and 52.1%, respectively. The clinical effects of efinaconazole were seen in more than half of the subjects. No severe adverse reactions related to efinaconazole were observed.Conclusion: The antifungal effect and safety of topically applied 10% efinaconazole solution in patients with mild to moderate toenail onychomycosis caused by dermatophytes was confirmed based on the efficacy and safety evaluation for a complete cure.